Auxilium Pharmaceuticals, a specialty bio-pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Xiaflex is a biologic approved in the US, EU, Canada and Australia for the treatment of adult DC patients with a palpable cord. DC is a progressive hand disease that can present with multiple collagen "cords" that limit finger joint movement and result in 70,000 procedures to treat affected patients every year1. It is estimated that 35 to 40 per cent of annual US surgical procedures to treat DC have been performed to treat at least two DC joints at a time.
"In my opinion, Xiaflex provides an effective non-surgical option for treating DC patients with two affected joints concurrently in one office visit," said Gary M. Pess, M.D., an orthopaedic hand surgeon with Central Jersey Hand Surgery. "In my practice, the expanded labeling will also allow flexibility in the scheduling process due to the ability to delay the finger manipulation procedure from 24 to up to 72 hours, which may be more convenient for patients."
The sBLA was based on positive results from the global, multicentre phase 3b MULTICORD (Multiple Treatment Investigation of Collagenase Optimising the Resolution of Dupuytren's) trial, together with data from Auxilium's earlier studies (AUX-CC-861 and AUX-CC-864). The MULTICORD study also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection. In phase 3b clinical trials, two concurrent Xiaflex injections were safely used in the treatment of one hand with multiple affected joints.
"We are pleased with the FDA approval of the sBLA for a labelling expansion for Xiaflex for the treatment of two Dupuytren's joints in the same hand concurrently and the ability to perform the finger extension procedure approximately 24 to 72 hours after injection," said Adrian Adams, chief executive officer and president of Auxilium Pharmaceuticals. "We believe this marks an important milestone for patients and physicians as it expands their options for treating two joints concurrently in one office procedure, which may result in less overall treatment time."
Auxilium has also worked with the FDA to modify the Xiaflex REMS to communicate a change to the wording of the contraindication in patients with a history of hypersensitivity to Xiaflex or other collagenase and to add information related to the risk of skin lacerations in the treated finger or hand of patients with Dupuytren's contracture.
DC is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with DC there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, affecting the joints and causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger joint's range of motion (how much a person can move or straighten them). Once the Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord."
Xiaflex (collagenase clostridium histolyticum, or CCH) is a biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord, and approved in the US for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. Xiaflex consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. Xiaflex has been granted Orphan status in the US by the FDA for DC and PD.